• Reference standards
  • Reference standards

Reference standards

Qualification of pharmaceutical reference standards:
primary and working standards

Experience

Our 28 years of experience in the manufacture, isolation, purification and qualification of pharmaceutical reference standards for quality control make us your trusted partner for reference standards.

In our GMP- and FDA-certified lab, we qualify our reference standards according to the latest scientific and technical knowledge, thereby meeting the current legal and regulatory requirements.

Choose the most suitable standard for your purpose from our portfolio.

 

 

Primary standards

Within the scope of qualifying primary standards we also test the identity, content and purity.

Identity testing

Identity testing using spectroscopic methods:

  • 1H-NMR and 13C-NMR spectroscopy, recording of coupled spectra as required
  • Mass spectroscopy
  • UV and/or IR spectroscopy
Assay

Assays using two independent methods:

  • Quantitative NMR or titration as an absolute method
  • Chromatographic purity using validated HPLC or GC separation systems including other impurities such as
    • Residual solvents (determination by validated GC separation systems)
    • Water content (Karl Fischer titration)
    • Inorganic impurities

Retesting the primary standards regularly ensures the contents over a defined period.

Dossier

The dossier on the primary standard contains the results of qualification including validation data, an interpretation of the spectroscopic data and an assessment of the specified contents. It can be directly incorporated in CTD modules 3.2.S.5 or 3.2.P.6.

Certificate of analysis

Besides the qualification results, the batch-specific certificate of analysis also includes details on the shelf life and recommended storage conditions as well as sample spectra and chromatograms.

Standards for research
and development
(R&D standards)

Our R&D standards are tested using chromatographic and spectroscopic methods and come with a batch-specific certificate of analysis.

 

 

Standards for identity
and purity testing
(ident-purity standards)

Ident-purity standards come with proof of identity, determined chromatographic purity and a batch-specific certificate of analysis.

 

 

Standards for assay
(assay standards)

We offer assay standards for pharmaceutical quality control as primary reference standards or working standards derived therefrom.

 

 

Working standards


We offer a wide range of working standards for quality control at an excellent price–performance ratio. The content of our working standards is derived from a qualified primary standard using a validated process. The identity is also verified.

Regular retests and pre-portioning in quantities for an analysis period ensure the stability of the working standard.

Please see our product range for the instant availability of our working standards. Other working standards can be supplied upon request.

Besides the qualification results, the batch-specific certificate of analysis also includes details on the shelf life and recommended storage conditions as well as sample spectra and chromatograms.

 

#referencestandard

Identity and purity standards

As part of the qualification of identity and purity standards we test identity and purity. Identity testing using spectroscopic methods:

  • 1H-NMR and 13C-NMR spectroscopy, recording of coupled spectra as required
  • Mass spectroscopy and/or UV and/or IR spectroscopy

Purity testing via chromatographic purity using HPLC or GC separating system.

Besides the qualification results, the batch-specific certificate of analysis also includes details on the recommended storage conditions as well as sample spectra and chromatograms.

 

Simone Schäfer
Sales Reference Standard

Phone: +49 7272 7767-16
Email:

Contact us. We’re happy to help!

Hotline

Monday - Friday
08:00 - 17:00 o´clock

+49 7272 7767-0